43 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code HRS·April 4, 2023
Zavation
FDA UDI
Zavation LLC·00842166184091·TRIAL SPACER, 6°, 16 X 26 X 60mm
OsteoMed
FDA UDI
OSTEOMED LLC·00845694041195·2.0mm, 8 Hole Curved Plate
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776185985·Operating Scissors str ss
DURAVENT
FDA UDI
Andreas Fahl Medizintechnik-Vertrieb GmbH·04051948004724·DURAVENT 1 IC, SIZE 11
OLSEN HEGAR NEEDLE HOLDER
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896046146·OLSEN HEGAR NEEDLE HOLDER CUSTOM DELICATE TUNGS...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694041201·2.0mm, 8 Hole Curved Plate, Sterile
NA
FDA UDI
Biedermann Motech GmbH & Co. KG·04250869688482·MOSS VRS PSO Pliers Connector 75mm
Embozene®
FDA UDI
BOSTON SCIENTIFIC CORPORATION·08714729943709·Microspheres for Embolization
OsteoMed
FDA UDI
OSTEOMED LLC·00845694063227·2.0 System 8 Hole Curved Plate Sterile Qty 2
Embozene®
FDA UDI
BOSTON SCIENTIFIC CORPORATION·08714729942504·Microspheres for Embolization
CARDIOIMMUNE TL CARDIAC MARKER CONTROL LEVELS 1, 2, 3, AND MULTI-PACK
FDA 510(k)
FDA Class 1
·Clinical Chemistry
FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
NEONATAL BUBBLE CPAP DUAL HEATED CIRCUIT KIT
FDA Adverse Event
Malfunction
·Product code BZE·March 3, 2021
Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD, Inc.·March 19, 2025
BUBBLE CPAP CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZD·April 19, 2011
UNKNOWN ZIMMER SCREW
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code HWC·June 21, 2017
UNKNOWN ZIMMER NATURAL NAIL
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·June 21, 2017
Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035
FDA Recall
Open, Classified
·Smiths Medical ASD, Inc.·Product code BTR·February 13, 2025